Medical Device Webinar Series Part 1: Achieving Successful Chemical Characterization of Medical Devices
A recently introduced set of medical device regulations calls for more thorough chemical testing for extractables and leachables and the establishment of robust risk-management processes aimed at enhancing patient safety. In complying with these new regulations, medical device manufacturers must carefully consider technologies and value-adding solutions that support an uninterrupted and accelerated route to market, including application of quality management software, improving data integrity, and leveraging modern instrumentation to gain greater insight into chemical and material characterization.
Join the discussion and hear first-hand how industry experts have built effective and compliant risk-management workflows that help smooth the path of medical device product to market.
Why Attend:
- Gain key insights into medical device regulations
- Learn the importance and how to implement data integrity and compliance
- Understand technologies and workflows for chemical characterization
- Considerations for LC-MS method development and using chemical libraries
Who Should Attend:
- Scientists, chemists, and managers who have an interest in medical device regulations and focus on extractable/leachable testing
- Medical device manufacturers, CxOs, and suppliers focusing on medical device testing
Achieving Successful Chemical Characterization of Medical Devices
The chemical characterization of medical devices has been increased in importance with the recent changes to the ISO series of guidances, particularly ISO 10993-18.
Presenter: Andrew Feilden, Ph.D. (European E&L Strategic Director, Hall Analytical)
Andrew Feilden joined Hall Analytical in November 2019 as the European E&L Strategic Director. He is a technical expert in the field of E&L testing, having been involved in the field of E&L for over 20 years. At Hall he undertakes Commercial, Operational and technical thought leadership activities. Andrew has presented on the field of extractables and leachables in over 16 countries worldwide. He has written a number of papers and publications and is the inventor of two patents. He has a degree and D Phil from the University of York, is a Fellow of the Royal Society of Chemistry, and was a Scientific Advisor to IPAC-RS and ex-co-chair of ELSIE.
